The following data is part of a premarket notification filed by Brainlab Ag with the FDA for Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial, Cirq Robotic Alignment Module, Cirq Robotic Alignment Cranial And Spine, Cirq Robotic Alignment Cranial And Spine System.
| Device ID | K210989 |
| 510k Number | K210989 |
| Device Name: | Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial, Cirq Robotic Alignment Module, Cirq Robotic Alignment Cranial And Spine, CIRQ Robotic Alignment Cranial And Spine System |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | Brainlab AG Olof-Palme-Str. 9 Munich, DE 81829 |
| Contact | Chiara Cunico |
| Correspondent | Chiara Cunico Brainlab AG Olof-Palme-Str. 9 Munich, DE 81829 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-02 |
| Decision Date | 2021-11-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056481141622 | K210989 | 000 |
| 04056481141608 | K210989 | 000 |
| 04056481141592 | K210989 | 000 |
| 04056481141585 | K210989 | 000 |
| 04056481141578 | K210989 | 000 |
| 04056481141561 | K210989 | 000 |
| 04056481144388 | K210989 | 000 |
| 04056481143701 | K210989 | 000 |